Asociación del antígeno ki67 y otros factores clínico patológicos con el Score de Oncotype DX en carcinomas luminales de mama / Association of the ki67 antigen and other clinicopathological factors with the Oncotype DX Score in luminal breast carcinomas

Introducción: Los tumores luminales presentan diferencias moleculares y distinto comportamiento. El antígeno ki67 (ki67) es uno de los factores que sirve para diferenciar entre luminal A y B. Las plataformas genómicas pueden identificar qué pacientes se benefician con quimioterapia. Objetivo: Establecer si existe asociación entre ki67 y Score de Oncotype Dx o score de recurrencia (SR). Evaluar la influencia del ki67 y el SR en la decisión terapéutica, evaluar la asociación entre riesgo clínico y SR, entre invasión linfovascular (ILV) y SR y entre axila positiva (hasta 1 ganglio) y SR. Material y método: Estudio retrospectivo, observacional, descriptivo. Se incluyeron 68 pacientes con tumores luminales Her2Neu negativos, T1-T2, axila negativa o positiva hasta 1 ganglio las cuales realizaron Oncotype DX entre 2009 y 2020 en el Hospital Alemán. Se clasificaron en SR menor o igual a 25 y mayor a 25 en base al estudio TAILORX donde se demostró que globalmente no hay beneficio con quimioterapia entre 0-25. Resultados: Se observó asociación entre ki67 y SR en 44 (64,7%) pacientes y fue mayor entre ki67 bajo y SR menor o igual a 25 (77,3%). El tratamiento se basó en el SR. Se observó asociación entre riesgo clínico y SR en 43 (63,2%) pacientes y fue mayor entre bajo riesgo clínico y SR menor o igual a 25 (87,5%). En un 88,8% no existió asociación entre ILV y SR, como así tampoco, entre axila positiva hasta 1 ganglio y SR en un 85,7%. Conclusiones: Es menester ofrecer a toda paciente con un tumor luminal una plataforma genómica ya que tanto el ki67 como otros factores clínicopatológicos por sí solos no demostraron ser superiores ni suficientes.

Introduction: Luminal tumors show molecular differences and different behavior. The antigen ki67 (ki67) is one of the factors that differentiate between luminal A and B. Genomic platforms can identify which patients will benefit from chemotherapy. Objective: To establish if there is an association between ki67 and Oncotype Dx Score or recurrence score (RS). To assess the influence of ki67 and RS on the therapeutic decision, to evaluate the association between clinical risk and RS, between lymphovascular invasion (LVI) and RS, and between positive armpit (up to 1 node) and RS. Material and method: Retrospective, observational, descriptive study. We included 68 patients with negative Her2Neu luminal tumors, T1-T2, negative or positive axillary up to 1 node, who performed Oncotype DX between 2009 and 2020 at Hospital Alemán. They were classified into RS less than or equal to 25 and greater than 25 based on the TAILORX study, where it was shown that overall there is no benefit from chemothe- rapy between 0-25. Results: An association was observed between ki67 and RS in 44 (64.7%) patients and it was greater between low ki67 and RS less than or equal to 25 (77.3%). The treatment was based on RS. An association between clinical risk and RS was observed in 43 (63.2%) patients, and it was greater between low clinical risk and RS less than or equal to 25 (87.5%). In 88.8% there was no association between LVI and RS, as well as between positive axillary up to 1 node and RS in 85.7%. Conclusions: It is necessary to offer every patient with a luminal tumor a genomic platform since both ki67 and other clinicopathological factors alone did not prove to be superior or sufficient.

Análise de custo-efetividade de um painel genético no câncer de mama precoce na saúde suplementar brasileira / Cost-effectiveness analysis of a genetic panel in early breast cancer in Brazilian supplementary health

Objetivo: Avaliar o custo-efetividade do uso de um painel genético de 21 genes em pacientes adultas diagnosticadas com câncer de mama em estádio inicial em uma operadora de saúde com mais de 500.000 vidas. Métodos: Foi utilizada uma coorte prospectiva seguida de um estudo de custo-efetividade entre os pacientes que utilizaram Oncotype DX® em 2020. Calcularam-se as despesas totais de cada esquema de quimioterapia (QT), somando-se os custos dos produtos e taxas de infusão. Resultados: Das 35 pacientes que utilizaram o teste de 21 genes no período avaliado, 60% (n = 21) não necessitaram de QT. Quando aplicadas simulações, houve custo evitado de R$ -1.945.448,88 (custos incrementais potenciais de R$ -6.488.207,56 até R$ 443.485,26, dependendo do esquema de QT escolhido). Conclusão: A inserção do teste de 21 genes na jornada do tratamento de câncer de mama na saúde suplementar evidenciou significativa relevância, pois contribuiu com o uso adequado da terapêutica, garantindo a sustentabilidade do sistema de saúde. Apresentando-se como uma opção custo-efetiva para a maioria dos esquemas de QT em comparação com a sua não utilização no tratamento, para a saúde suplementar brasileira

Objective: To evaluate the cost-effectiveness of the use of a genetic panel of 21 genes in adult patients diagnosed with early stage breast cancer in a healthcare provider with more than 500,000 lives. Methods: A prospective cohort study was conducted, followed by cost-effectiveness, among patients who used Oncotype DX® , in 2020. The total costs of each chemotherapy scheme (QT) were calculated, adding the costs of the products and infusion fees. Results: Of the 35 patients who used 21 gene tests in the evaluation period, 60% (n = 21) did not require QT. When simulations were applied, there was an avoided cost of R$ -1.945.448,88 (Potentials incremental costs from -R$ 6.488.207,56 to +R$ 443.485,26, depending on the chosen QT scheme). Conclusion: The insertion of 21-Gene recurrence score in the breast cancer treatment journey in supplementary health showed significant relevance, as it contributes to the appropriate use of therapy, guaranteeing the sustainability of the health system. Presenting itself as a cost-effective option for most QT schemes compared to not being used in treatment, for Brazilian supplementary health System

Prognostic value of the 21-gene recurrence score in ER-positive, HER2-negative, node-positive breast cancer was similar in node-negative diseases: a single-center study of 800 patients / 医学前沿

Multi-gene assays have emerged as crucial tools for risk stratification in early-stage breast cancer. This study aimed to evaluate the prognostic significance of the 21-gene recurrence score (RS) in Chinese patients with pN0-1, estrogen receptor-positive (ER

Prognosis analysis and 21-gene recurrence score according to TAILORx standard in hormone receptor positive early-stage breast cancer / 中华普通外科杂志

Objective To explore the association of 21 gene recurrence score (RS)according to TAILORx standard and prognosis of hormone receptor (HR) positive,axillary lymph node negative breast cancer.Methods The clinicopathologic data of 558 early breast cancer patients who underwent 21 gene RS testing from May 2012 to Jan 2017 were retrospectively analyzed.RS was subgrouped according to TAILORx standard.Estimates of relapse free survival(RFS) were made from the Kaplan-Meier curves.Results In 558 patients,RS≤10,RS 11-25 and RS≥26 groups accounted for 23.1％,63.6％ and 13.3％.After a median follow-up of 38 months,the recurrence ratesin RS ≤ 10,RS 11-25 and RS ≥ 26 groups were 3.3 ％,4.5％ and 5.4％,respectively.Kaplan-Meier RFS curve showed no significant difference between the 3 groups(P =0.788).The recurrence ratesin RS ≤ 15 group(3.0％) was significantly lower than that in RS≥ 16 group(5.9％)(P =0.041).Conclusions A significant association exists between RS and breast cancer prognosis.It is rational not to give chemotherapy to RS ＜ 18 low risk patients according to classical standard.

Prognosis analysis and 21-gene recurrence score according to TAILORx standard in hormone receptor positive early-stage breast cancer / 中华普通外科杂志

Objective@#To explore the association of 21 gene recurrence score(RS)according to TAILORx standard and prognosis of hormone receptor(HR) positive, axillary lymph node negative breast cancer.@*Methods@#The clinicopathologic data of 558 early breast cancer patients who underwent 21 gene RS testing from May 2012 to Jan 2017 were retrospectively analyzed. RS was subgrouped according to TAILORx standard.Estimates of relapse free survival(RFS) were made from the Kaplan-Meier curves.@*Results@#In 558 patients, RS≤10, RS 11-25 and RS≥26 groups accounted for 23.1%, 63.6% and 13.3%.After a median follow-up of 38 months, the recurrence ratesin RS≤10, RS 11-25 and RS≥26 groups were 3.3%, 4.5% and 5.4%, respectively. Kaplan-Meier RFS curve showed no significant difference between the 3 groups(P=0.788). The recurrence ratesin RS≤15 group(3.0%) was significantly lower than that in RS≥16 group(5.9%)(P=0.041).@*Conclusions@#A significant association exists between RS and breast cancer prognosis.It is rational not to give chemotherapy to RS<18 low risk patients according to classical standard.

Impact of the 21-gene recurrence score assay in clinical treatment and prognosis analysis for patients with hormone receptor positive early-stage breast cancer / 中华肿瘤杂志

Objective@#To explore the association between the 21-gene recurrence score (RS) and clinicopathologic characteristics as well as prognosis in patients with axillary lymph node negative, hormone receptor (HR) positive breast cancer.@*Methods@#The clinicopathologic data of 439 early breast cancer patients who underwent 21 gene RS testing was retrospectively analyzed. According to the 21 gene RS, the patients were divided into low risk (295 cases), intermediate risk (111 cases) and high-risk (33 cases) group. The relationship between the 21 gene RS and clinicopathological characteristics, treatment, recurrence and metastasis was analyzed. Univariate and multivariate statistical analyses were used to analyze the risk factors for relapse free survival (RFS).@*Results@#Tumor grade, estrogen receptor (ER), progesterone receptor (PR) and Ki-67 index were significantly different among the 3 risk cohorts (P<0.001 for all). After a median follow-up of 32 months, the recurrence rate in low risk group (3.7%) was significantly lower than that in the intermediate-high risk group (9.0%), the locoregional recurrence (LRR) rate of low, intermediate and high risk group was 2.4%, 6.3% and 9.1%; and the distant metastasis (DM) rate in low risk group was 1.4% and 2.1% in the intermediate-high risk group. Univariate analysis showed RS, ER status and endocrine therapy were prognostic factors for RFS (P<0.05 for all). Multivariate analysis showed that RS was an independent significant predictor for RFS (P=0.04).@*Conclusions@#The 21-gene RS is related to tumor grade, ER, PR and Ki-67 index. RS is an independent risk factor for RFS in patients with hormone receptor positive early-stage breast cancer.

Impacto del Score de Recurrencia de 21 genes en la indicación de tratamiento sistémico adyuvante: nuestra experiencia en el Hospital Italiano de Buenos Aires / Impact of the Recurrence Score on clinical decision-making about chemotherapy in the adjuvant setting: our experience at Hospital Italiano of Buenos Aires (Argentina)

Introducción Las plataformas genómicas han tomado gran relevancia como factores pronósticos y predictivos para definir tratamiento adyuvante en pacientes con cáncer de mama. Su uso permitiría discriminar un subgrupo de pacientes en quienes la indicación de quimioterapia podría ofrecer más morbilidad que verdadero beneficio. Objetivos Describir las características de las pacientes en quienes se utilizó la plataforma Oncotype DX® y evaluar el impacto del Score de Recurrencia (Recurrence Score) como herramienta de decisión para la indicación de adyuvancia. Material y método Se consideraron pacientes operadas entre 2013 y 2017 en el Hospital Italiano de Buenos Aires, Argentina, con diagnóstico de carcinoma invasor primario de mama de subtipo Luminal A o B, her2neu negativas. Se seleccionaron los casos en los que se solicitó Oncotype DX® y se describieron sus características clínicas e histológicas. Resultados Se utilizó Oncotype DX® en 47 pacientes con cáncer de mama invasor. En el 48,9% se obtuvo un Recurrence Score de riesgo bajo, en el 40,4% de riesgo intermedio y en el 10,6% de riesgo alto. En 22 casos (46,8%) consideramos que hubo un cambio de conducta en la indicación de adyuvancia. Conclusiones En nuestra experiencia, hemos visto que la plataforma genómica Oncotype DX® sería una herramienta útil para definir tratamiento adyuvante en tumores de tipo Luminal, her2neu negativo.

Introduction Over the past decade, gene expression assays have become relevant prognostic factors for guiding clinical decision-making in patients with breast cancer. Their use allows to discriminate which patients are most likely to benefit from chemotherapy in the adjuvant setting, avoiding unnecessary toxicity. Objectives To describe the clinical and pathologic characteristics of patients in whom Oncotype DX® was used as a prognostic factor and assess the impact of the Recurrence Score on clinical decision-making. Materials and method Patients who underwent surgery at the Hospital Italiano de Buenos Aires, Argentina, between 2013 and 2017 for Estrogen-Receptor positive (er+), her2neu negative primary breast cancer were considered eligible. We evaluated the cases in which Oncotype DX® was ordered and described the clinical and pathologic characteristics, as well as whether Recurrence Score (rs) modified the prescription of adjuvant therapy. Results Oncotype DX® was performed in 47 patients. The distribution of patients according to rs was as follows: low risk rs 48,9%, intermediate risk 40,4% and high risk 10,6%. We considered that adjuvant therapy decision was modified after rs in 22 patients (46,8%). Conclusions Oncotype DX® and its resulting Recurrence Score appear to be a clinically useful tool for decision-making in the adjuvant setting for patients with er+, her2neu negative breast cancer.

Effect of 21-gene recurrence score on chemotherapy decisions for patients with estrogen receptor-positive, epidermal growth factor receptor 2-negative and lymph node-negative early stage-breast cancer / 中华肿瘤杂志

Objective@#To investigate the effect of 21-gene recurrence score on adjuvant chemotherapy decisions for patients with estrogen receptor (ER)-positive, epidermal growth factor receptor 2 (HER-2)-negative and lymph node (LN)-negative early stage-breast cancer.@*Methods@#One hundred and forty-eight patients with ER+ , HER-2- and LN- early stage breast cancer were recruited in the Ruijin hospital, Shanghai Jiao Tong University School of Medicine. The 21-gene recurrence score (RS)assay was performed and systemic therapeutic decisions were made before and after knowing the RS results under multidisciplinary discussion. The effects of RS assay and the other influential factors on adjuvant chemotherapy decision were further analyzed.@*Results@#After knowing the RS results, treatment decisions were changed in 26 out of 148 patients(17.6%). Among them, 9 out of 26 patients were not recommended for chemotherapy; 16 of 26 had treatment recommendation changed to chemotherapy, and chemotherapy regimen was changed in the last one patient. Multivariate analysis showed that RS, age and histological grade were independent factors of decision-making for adjuvant chemotherapy.@*Conclusion@#Our results suggest that 21-gene recurrence score significantly influences decision making for adjuvant chemotherapy in patients with ER+ , HER-2- and LN- early stage breast cancer.